Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopic gastric bypass; Procedure: Laparoscopic VBG

• Registration Number: NCT01639677
• Lead Sponsor: Göteborg University

Brief Summary

This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2001-04
• Study Completion: 2010-08
• Study First Submitted: 2011-09-22
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-13
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI 35-50 kg/m2
• 20-60 y

Exclusion Criteria

• Severe co-morbidity
• Unmotivated to long term follow up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic gastric bypass	Laparoscopic gastric bypass	-
Laparoscopic VBG	Laparoscopic VBG	Laparoscopic vertical banded gastroplasty

Primary Outcome Measures

Name	Time	Method
Weight loss	1, 2, 5 and 10 years after surgery

Secondary Outcome Measures

Name	Time	Method
Body composition	1, 2, 5 and 10 years after surgery
Eating pattern	1, 2, 5 and 10 years after surgery
Energy expenditure	1, 2, 5 and 10 years after surgery
Gut hormonal response	4 and 10 years after surgery

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Gothenburg, Sweden